NCT05554484

AMI-DC in Patients With Anterior Wall Myocardial Infarction

A Multi-center, Controlled, Open, Phase I Clinical Trial to Assess the Safety of AMI-DC (Autologous Dendritic Cells) Treatment in Patients With Acute Anterior Wall ST-segment Elevation Myocardial Infarction Who Received Reperfusion by Primary Percutaneous Coronary Intervention (PCI)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Catholic University of Korea · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to assess the safety of AMI-DC treatment. The participants who voluntarily sign the consent form will be screened according to the inclusion/exclusion criteria then allocated either to the experimental group (drug therapy and AMI-DC therapy) or to the control group (drug therapy only). Both the experimental group and the control group are treated with standard medical therapy after PCI. The experimental group will be hospitalized for 4-5 days after 1st injection, and 1 day after 2nd injection. Vital signs are collected after 30 minutes, 1 hour, 2 hours and 4 hours after the 1st and 2nd injections and the subjects will be monitored 24 hours for safety assessment. The identical examination will also be performed in the control group and the results will be collected.

Detailed description

The registration of study subjects follows two stages (stages A \& B). In Stage A, 6 subjects in the experimental group and 3 subjects in the control group will sequentially be registered, then will be monitored for 10 weeks to assess safety. If Stage A passes the safety assessment, the rest will be recruited and randomly allocated to either experimental or control group in Stage B. Approximately 300cc of whole blood will be collected only from patients assigned to the experimental group. The amount of blood collection can be supervised and adjusted at the discretion of the investigators. Collected blood will be cultured for 4 days to generate the dendritic cells. Then, 5\~10x106 cells are administered subcutaneously at 1-4 sites in the left axillary regions between 5-7 days after PCI and between 12-14 days after PCI. Echocardiography and cardiac MRI will be examined for any signs of adverse reaction to ensure safety and evaluate cardiac functions at baseline and after 6 months. * In stage A, 6 people are sequentially allocated to the experimental group and 3 people are sequentially allocated to the control group. * The experimental group are monitored for 10 weeks following the 2nd AMI-DC to assess safety. Stage B is implemented once determined safe to proceed.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
BIOLOGICAL	Autologous peripheral blood-derived tolerogenic dendritic cells	AMI-DC, autologous dendritic cell product Inject 7.5 x 106 cells hypodermically to 1\~4 sites in the left axillary lymph node between 5-7 days after PCI and 12-14 days after PCI. . The administration must be done within 30 minutes after fully liquified.

Timeline

• Start date: 2021-06-07
• Primary completion: 2023-07-01
• Completion: 2023-10-30
• First posted: 2022-09-26
• Last updated: 2022-09-26

Locations

1 site across 1 country: South Korea